- Veterans Affairs, Veterans Health Administration (Houston, TX)
- …administrative duties, including the performance and documentation of QC required to maintain compliance with all QC and QA requirements as per VHA policy, FDA ... the breast imaging section and assisting the department at annual FDA /MQSA inspections. The incumbent works closely with technologists, radiologists, clinicians, and… more
- Kedplasma (San Antonio, TX)
- …Center Manager in all aspects of center performance, including quality and compliance , operations, and financial aspects including strategies and assures the company ... developed and maintained. Operates within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make… more
- Biomat USA, Inc. (Corpus Christi, TX)
- …for overseeing day-to-day operational performance to ensure donor safety, regulatory compliance , and achievement of production goals. This role provides direct ... : Assists with operational management of a Plasma Collection Center, ensuring compliance with all applicable policies and regulations and overall performance and… more
- Sumitomo Pharma (Austin, TX)
- …relevant external advertising & promotional regulations or codes of practice (eg, FDA regulations, PhRMA guidelines, etc.) and are consistent with company guiding ... of promotional materials, eg Marketing and their Agencies, Legal, Compliance , and Medical Affairs. + Provide appropriate oversight of...with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on … more
- Stryker (Flower Mound, TX)
- …cross-functional teams to ensure the highest standards of product safety and compliance . **What you will do:** + Provide guidance on cleaning, disinfection, ... teams and authorities. + Participate in internal and external audits ( FDA , notified bodies), addressing sterilization and biocompatibility topics. + Apply ISO,… more
- Fujifilm (Austin, TX)
- …on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations specific to Life Sciences/Pharma companies. + Provide ... to HLUS and its subsidiary companies on substantive legal topics, including FDA marketing and advertising regulations and other regulations specific to Life… more
- Veterans Affairs, Veterans Health Administration (Temple, TX)
- …administrative duties, including the performance and documentation of QC required to maintain compliance with all QC and QA requirements as per VHA policy, FDA ... the breast imaging section and representing the department at annual FDA /MQSA inspections. Working closely with the technologists, radiologists, clinicians, and… more
- Merck (Austin, TX)
- …with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. **Primary ... submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. + Interact independently with regulatory agencies (… more
- CSL Plasma (Houston, TX)
- …facility compliance with CSL procedures and policies, cGMP, OHSA, FDA , and other regulations, as applicable, and develop center responses for deficiencies. ... Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all...include, but not limited to: ADA, Civil Rights, EEOC, FDA , GHA, HIPAA, and OSHA. + Maintain confidentiality of… more
- United Therapeutics (Austin, TX)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... teams such as: marketing, clinical development, medical affairs, public policy, and compliance to ensure that patient advocacy and medical society initiatives are… more